EN ISO 80369-1:2018
(Main)Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2018)
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2018)
This document specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or accessories intended for use with a patient.
This document also specifies the healthcare fields in which these small-bore connectors are intended to be used.
These healthcare fields include, but are not limited to:
— breathing systems and driving gases;
— enteral;
— limb cuff inflation;
— neuraxial;
— intravascular or hypodermic.
This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that will be developed under future parts of the ISO 80369 series.
This document does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.
NOTE 1 Clause 7 allows for additional designs of small-bore connectors for new applications for inclusion in the ISO 80369 series.
NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in the ISO 80369 series into medical devices, medical systems or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, the risks associated with changing to the new small-bore connectors as specified in the ISO 80369 series of standards will be considered.
NOTE 3 The connectors specified in the ISO 80369 series are intended for use only in their specified application. Use of these connectors for other applications increases risk that a hazardous misconnection could occur.
NOTE 4 Manufacturers and responsible organizations are encouraged to report their experience with the small-bore connectors specified in the ISO 80369 series to the Secretariat of ISO/TC 210 so that this feedback can be considered during the revision of the relevant part of the ISO 80369 series.
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 1: Allgemeine Anforderungen (ISO 80369-1:2018)
Dieses Dokument legt allgemeine Anforderungen für VERBINDUNGSSTÜCKE MIT KLEINEM DURCHMESSER fest, die Flüssigkeiten oder Gase in ANWENDUNGEN der medizinischen Versorgung führen. Diese VERBINDUNGSSTÜCKE MIT KLEINEM DURCHMESSER werden bei MEDIZINPRODUKTEN oder ZUBEHÖR zur ANWENDUNG bei PATIENTEN eingesetzt.
Dieses Dokument legt auch die medizinischen Bereiche fest, für die diese VERBINDUNGSSTÜCKE MIT KLEINEM DURCHMESSER zweckbestimmt sind.
Diese Anwendungsbereiche der medizinischen Versorgung umfassen folgende ANWENDUNGEN, sind aber nicht darauf beschränkt:
— ATEMSYSTEME und Antriebsgase;
— enterale ANWENDUNGEN;
— urethrale und urologische ANWENDUNGEN;
— aufblasbare Manschetten für Gliedmaßen;
— neuroaxiale Produkte;
— intravaskuläre oder hypodermische ANWENDUNGEN.
Dieses Dokument liefert die Methodologie zur Beurteilung der Merkmale der NICHT MITEINANDER VERBINDBARKEIT von VERBINDUNGSSTÜCKEN MIT KLEINEM DURCHMESSER auf der Grundlage ihrer inhärenten Ausführung und Maße, mit dem Ziel, das RISIKO von Fehlverbindungen zwischen MEDIZINPRODUKTEN oder zwischen den ZUBEHÖR¬teilen für unterschiedliche ANWENDUNGEN, die in diesem Dokument festgelegt sind, sowie wie auch für allen anderen, die nach den zukünftigen Teilen der Normenreihe ISO 80369 entwickelt werden, herabzusetzen.
Dieses Dokument legt keine Anforderungen an MEDIZINPRODUKTE oder ZUBEHÖR fest, die diese VERBINDUNGS-STÜCKE MIT KLEINEM DURCHMESSER nutzen. Derartige Anforderungen finden sich in den jeweiligen Internationalen Normen für bestimmte(s) MEDIZINPRODUKTE oder ZUBEHÖR.
ANMERKUNG 1 Abschnitt 7 berücksichtigt zusätzliche Ausführungen von VERBINDUNGSSTÜCKEN MIT KLEINEM DURCHMESSER für neue ANWENDUNGEN zur Aufnahme in die Normenreihe ISO 80369.
ANMERKUNG 2 Die HERSTELLER werden bestärkt, die in der Normenreihe ISO 80369 festgelegten VERBINDUNGSSTÜCKE MIT KLEINEM DURCHMESSER in MEDIZINPRODUKTE, Medizinsysteme oder ZUBEHÖR zu integrieren, auch wenn dies von den jeweils zutreffenden Normen für MEDIZINPRODUKTE gegenwärtig nicht gefordert wird. Es wird erwartet, dass bei der Überarbeitung der jeweils zutreffenden Normen für MEDIZINPRODUKTE die Anforderungen an VERBINDUNGSSTÜCKE MIT KLEINEM DURCHMESSER entsprechend den Festlegungen in der Normenreihe ISO 80369 aufgenommen werden.
ANMERKUNG 3 Die in der Normenreihe ISO 80369 festgelegten VERBINDUNGSSTÜCKE sind für ihre festgelegte ANWENDUNG zweckbestimmt. Der Einsatz dieser VERBINDUNGSSTÜCKE für andere Zwecke erhöht das RISIKO, dass eine gefährliche Verbindung entstehen könnte.
ANMERKUNG 4 Die HERSTELLER und VERANTWORTLICHEN ORGANISATIONEN sind angehalten, ihre Erfahrungen mit den in der Normenreihe ISO 80369 festgelegten VERBINDUNGSSTÜCKEN MIT KLEINEM DURCHMESSER dem Sekretariat des ISO/TC 210 mitzuteilen, so dass diese Rückmeldungen bei der Überarbeitung des entsprechenden Teils der Normenreihe ISO 80369 berücksichtigt werden können.
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie 1: Exigences générales (ISO 80369-1:2018)
Le présent document spécifie les exigences générales relatives aux raccords de petite taille qui transportent des liquides ou des gaz dans les applications de soins de santé. Ces raccords de petite taille sont utilisés dans des dispositifs médicaux ou des accessoires destinés à être employés sur un patient.
Le présent document spécifie également les domaines de la santé dans lesquels ces raccords de petite taille sont destinés à être employés.
Ces domaines comprennent, sans toutefois s'y limiter, les éléments suivants:
— systèmes respiratoires et gaz d'entraînement;
— applications entérales;
— applications de gonflage autour des membres;
— applications en contact avec le système nerveux;
— applications intravasculaires ou hypodermiques.
Le présent document indique la méthodologie à suivre pour évaluer les caractéristiques de non-raccordabilité des raccords de petite taille en s'appuyant sur leur conception et leurs dimensions intrinsèques, afin de réduire le risque d'erreur de raccordement entre des dispositifs médicaux ou entre des accessoires destinés à différentes applications qui sont spécifiées dans le présent document ou qui seront développées dans les futures parties de la série ISO 80369.
Le présent document ne spécifie pas d'exigences relatives aux dispositifs médicaux ou aux accessoires sur lesquels ces raccords de petite taille sont utilisés. Ces exigences figurent dans des Normes internationales spécifiques traitant de dispositifs médicaux ou d'accessoires particuliers.
NOTE 1 L'Article 7 permet l'intégration de modèles de raccords de petite taille supplémentaires destinés à de nouvelles applications dans la série ISO 80369.
NOTE 2 Les fabricants sont incités à intégrer les raccords de petite taille spécifiés dans la série ISO 80369 dans les dispositifs médicaux, les systèmes médicaux ou les accessoires, même si cela n'est pas actuellement requis par les normes appropriées spécifiques de ces dispositifs médicaux. Il est prévu de considérer les risques associés au remplacement des raccords de petite taille spécifiés dans la série de normes ISO 80369 lors de la révision des normes appropriées spécifiques de ces dispositifs médicaux.
NOTE 3 Les raccords spécifiés dans la série ISO 80369 sont destinés à être utilisés uniquement pour l'application spécifiée. L'utilisation de ces raccords pour d'autres applications augmente le risque d'erreur de raccordement dangereuse.
NOTE 4 Les fabricants et les organismes responsables sont incités à faire part de leur expérience concernant les raccords de petite taille spécifiés dans la série ISO 80369 au Secrétariat de l'ISO/TC 210, de sorte que leurs commentaires puissent être pris en compte lors de la révision de la partie appropriée de la série ISO 80369.
Priključki z majhnim premerom za tekočine in pline za uporabo v zdravstvu - 1. del: Splošne zahteve (ISO 80369-1:2018)
Ta dokument določa splošne zahteve za priključke z majhnim premerom, ki se uporabljajo za prenos tekočin in plinov, za uporabo v zdravstvu. Ti priključki z majhnim premerom se uporabljajo v medicinskih pripomočkih ali dodatkih, predvidenih za uporabo s pacientom.
Ta dokument določa tudi zdravstvena področja, na katerih je predvidena uporaba teh priključkov z majhnim premerom.
Ta zdravstvena področja med drugim vključujejo:
– dihalne sisteme in pogonske pline;
– enteralno uporabo;
– raztegljivo manšeto za okončine;
– nevroaksialno uporabo;
– intravaskularno ali hipodermično uporabo.
Ta dokument podaja metodologijo za ocenjevanje lastnosti medsebojne povezljivosti priključkov z majhnim premerom na podlagi njihove zasnove in dimenzij za zmanjšanje tveganja napačnih povezav med medicinskimi pripomočki ali med dodatki za različne vrste uporabe, kot je določeno v tem dokumentu, in tistimi, ki bodo razviti v prihodnjih delih skupine standardov ISO 80369.
Ta dokument ne določa zahtev za medicinske pripomočke ali dodatke, ki uporabljajo te priključke z majhnim premerom. Takšne zahteve so podane v ustreznih mednarodnih standardih za posamezne medicinske pripomočke ali dodatke.
OPOMBA 1: Točka 7 omogoča obravnavo dodatnih zasnov priključkov z majhnim premerom za nove načine uporabe za vključitev v skupino standardov ISO 80369.
OPOMBA 2: Proizvajalcem se priporoča, da priključke z majhnim premerom, opredeljene v skupini standardov
ISO 80369, vključijo v medicinske pripomočke, medicinske sisteme ali dodatke, tudi če ustrezni posamezni standardi za medicinske pripomočke trenutno tega ne zahtevajo. Predvideva se, da se ob reviziji ustreznih posameznih standardov za medicinske pripomočke upoštevajo tudi tveganja, povezana s prehodom na priključke z majhnim premerom, kot so določeni v skupini standardov ISO 80369.
OPOMBA 3: Priključki, opredeljeni v skupini standardov ISO 80369, so namenjeni samo za predvidene načine
uporabe. Drugi načini uporabe tovrstnih pripomočkov povečujejo tveganje za vzpostavitev nevarne nepravilne povezave.
OPOMBA 4: Proizvajalcem in odgovornim organizacijam se priporoča, da poročajo o izkušnjah s priključki z majhnim premerom, opredeljenimi v skupini standardov ISO 80369, sekretariatu ISO/TC 210, ki bo povratne informacije upošteval pri reviziji ustreznega dela skupine standardov ISO 80369.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2019
1DGRPHãþD
SIST EN ISO 80369-1:2011
3ULNOMXþNL]PDMKQLPSUHPHURP]DWHNRþLQHLQSOLQH]DXSRUDERY]GUDYVWYXGHO
6SORãQH]DKWHYH ,62
Small bore connectors for liquids and gases in healthcare applications - Part 1: General
requirements (ISO 80369-1:2018)
Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in
medizinischen Anwendungen - Teil 1: Allgemeine Anforderungen (ISO 80369-1:2018)
Raccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé - Partie
1: Exigences générales (ISO 80369-1:2018)
Ta slovenski standard je istoveten z: EN ISO 80369-1:2018
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 80369-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2018
ICS 11.040.10; 11.040.20
Supersedes EN ISO 80369-1:2010
English version
Small-bore connectors for liquids and gases in healthcare
applications - Part 1: General requirements (ISO 80369-
1:2018)
Raccords de petite taille pour liquides et gaz utilisés Verbindungsstücke mit kleinem Durchmesser für
dans le domaine de la santé - Partie 1: Exigences Flüssigkeiten und Gase in medizinischen
générales (ISO 80369-1:2018) Anwendungen - Teil 1: Allgemeine Anforderungen
(ISO/FDIS 80369-1:2018)
This European Standard was approved by CEN on 20 November 2017.
CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for
giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical
references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to
any CEN and CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN and CENELEC member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
CEN-CENELEC Management Centre:
Rue de la Science 23, B-1040 Brussels
© 2018 CEN/CENELEC All rights of exploitation in any form and by any means Ref. No. EN ISO 80369-1:2018 E
reserved worldwide for CEN national Members and for
CENELEC Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 80369-1:2018) has been prepared by Technical Committee ISO/TC 210 "Quality
management and corresponding general aspects for medical devices" in collaboration with Technical
Committee CEN/CLC/JTC 3 “Quality management and corresponding general aspects for medical
devices” the secretariat of which is held by NEN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by May 2019, and conflicting national standards shall be
withdrawn at the latest by May 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 80369-1:2010.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 80369-1:2018 has been approved by CEN as EN ISO 80369-1:2018 without any
modification.
INTERNATIONAL ISO
STANDARD 80369-1
Second edition
2018-11
Small-bore connectors for liquids and
gases in healthcare applications —
Part 1:
General requirements
Raccords de petite taille pour liquides et gaz utilisés dans le domaine
de la santé —
Partie 1: Exigences générales
Reference number
ISO 80369-1:2018(E)
©
ISO 2018
ISO 80369-1:2018(E)
© ISO 2018
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
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Published in Switzerland
ii © ISO 2018 – All rights reserved
ISO 80369-1:2018(E)
Contents Page
Foreword .iv
Introduction .v
1 *Scope . 1
2 *Normative references . 2
3 Terms and definitions . 2
4 *Materials . 4
5 Small-bore connector incompatibility . 4
6 *Clinical applications . 4
6.1 *Additional small-bore connector designs . 4
6.2 Enteral applications . 5
6.3 Limb cuff inflation applications . 5
6.4 Neuraxial applications . 5
6.5 Intravascular or hypodermic applications . 5
7 *Alternative small-bore connectors. 5
Annex A (informative) Rationale . 7
Annex B (normative) Test methods for demonstrating non-interconnectable characteristics .11
Annex C (informative) Symbols and safety signs .24
Annex D (normative) Assessment procedures small-bore connectors .25
Annex E (informative) Applications of small-bore connectors .27
Annex F (informative) Reference to the Essential Principles .29
Bibliography .30
Alphabetized index of defined terms.31
ISO 80369-1:2018(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso
.org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 210, Quality management and
corresponding general aspects for medical devices, in collaboration with IEC/TC 62, Electrical equipment
in medical practice, Subcommittee SC D, Electromedical equipment and CEN/CENELEC TC 3/WG 2, Small-
bore connectors.
This second edition cancels and replaces the first edition (ISO 80369-1:2010), which has been technically
revised.
A list of all parts in the ISO 80369 series can be found on the ISO website.
The main changes compared to the previous edition are as follows:
— the normative references have been updated;
— the requirement for Alternative small-bore connectors, including disclosure and marking
requirements have been updated;
— in Annex B, the Test methods for demonstrating non-interconnectable characteristics to
reflect the testing used in the development of ISO 80369-2, ISO 80369-3, IEC 80369-5, ISO 80369-6
and ISO 80369-7 have been updated;
— Annex D has been created with the Assessment procedures small-bore connectors which
replaces Clause 7 of the previous edition and contains a description of the computer aided design
(CAD) analysis that was used in the evaluation of the non-interconnectable characteristics.
A list of all parts in the ISO 80369 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2018 – All rights reserved
ISO 80369-1:2018(E)
Introduction
In the 1990s, concern grew regarding the proliferation of medical devices fitted with Luer connectors
as specified in ISO 80369-7 and the reports of patient death or injury arising from misconnections that
resulted in the inappropriate delivery of enteral solutions, intrathecal medication or compressed gases.
Concerns regarding the use of Luer connectors with enteral feeding tubes and gas sampling and gas
delivery systems were raised with CEN/BT
...
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